NX01 (NX01)
Naox Technologies SasThe NX01 is a wearable EEG device designed as earbuds that continuously record one channel of brain electrical activity. Intended for use in healthcare and home settings, it allows licensed medical professionals to access EEG data for patient monitoring. By integrating dry electrodes into earbuds, the device provides a compact and comfortable solution for long-term brain activity recording in adults and pediatric patients 6 years and older.
Intended Use
NX01 is intended for use in healthcare or home settings to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes in the ears of patients. It acquires, records and transmits one channel of electroencephalogram (EEG) data. The medical use of data acquired by NX01 is to be performed under the direction and interpretation of a licensed medical professional.
Technology
NX01 consists of earbuds with integrated dry active electrodes connected to a command panel housing battery, memory, acquisition unit, and status LEDs. It records continuous EEG data through a single bipolar EEG channel, stores data in European Data Format (.edf), and is powered by a low-voltage rechargeable battery. The device complies with IEC 60601 standards for electrical safety, electromagnetic compatibility, and usability.
Performance
NX01 underwent design verification, usability, and human factors testing. Independent laboratory testing confirmed compliance with IEC standards for electrical safety, EMC, and EEG performance. Clinical studies in healthy subjects, epilepsy patients, and hardware-in-the-loop simulations demonstrated that NX01 provides reliable EEG data comparable to predicate devices without safety concerns.
Predicate Devices
No predicate devices specified
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